BAAT Medical
BAAT Medical offers end-to-end solutions for medical device innovation, from strategy and funding to development, manufacturing, and regulatory compliance. They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.
BAAT Medical is a comprehensive partner for medical device innovators, providing end-to-end solutions to bring cutting-edge technologies to market. They cater to a range of medical devices, from Class I to Class III, including instruments, wearables, (smart) implants, custom-made products, and medicinal combination devices. Their expertise spans the entire product lifecycle, starting with strategic evaluation of the device idea, market research, and business case development. They assist in securing funding, guiding startups and established companies through the financial landscape. The development phase is handled with a focus on turning concepts into tangible, market-ready products, ensuring innovative design and regulatory compliance. BAAT Medical also excels in manufacturing, scaling production to meet market demands while maintaining quality and readiness for approval. Furthermore, they offer robust regulatory affairs support, including navigating complex regulations like the MDR, and act as the Legal Manufacturer for custom-made devices, ensuring patient safety and compliance. Their proven process minimizes risks and optimizes for successful market entry or exits, helping clients achieve real-world impact in medical device innovation.
About
**Who they are**
BAAT Medical is an end-to-end solutions provider for medical device innovation, focusing on bringing devices from strategy and funding through development, manufacturing, and regulatory compliance to market.
**Expertise & scope**
* End-to-end solutions for medical device innovation
* Specialization in Class I-III devices, including implants and wearables
* Regulatory compliance, particularly for 3D-printed medical devices under MDR
* Acting as the Legal Manufacturer for custom-made 3D-printed products, issuing Statements Annex XIII
* Services include strategy development, market research, business case development, funding support, product development, manufacturing streamlining, and market launch.
**Reputation / proof points**
* Covers the EU market.
* Partnership with 3DMM for MDR-compliant 3D-printed devices.
BAAT Medical is an end-to-end solutions provider for medical device innovation, focusing on bringing devices from strategy and funding through development, manufacturing, and regulatory compliance to market.
**Expertise & scope**
* End-to-end solutions for medical device innovation
* Specialization in Class I-III devices, including implants and wearables
* Regulatory compliance, particularly for 3D-printed medical devices under MDR
* Acting as the Legal Manufacturer for custom-made 3D-printed products, issuing Statements Annex XIII
* Services include strategy development, market research, business case development, funding support, product development, manufacturing streamlining, and market launch.
**Reputation / proof points**
* Covers the EU market.
* Partnership with 3DMM for MDR-compliant 3D-printed devices.
Additional information
BAAT Medical emphasizes its role as a Legal Manufacturer for specific custom-made 3D-printed medical devices, particularly under the MDR. They validate production processes and create technical files to ensure compliance. For buyers considering this route, BAAT Medical issues a Statement Annex XIII, confirming MDR compliance for Class IIa devices. While hospitals retain responsibility for clinical use, BAAT Medical assumes accountability as the Legal Manufacturer for the product's safety, biocompatibility, and cleanliness, addressing potential confusion regarding responsibility, especially concerning sterilization and product fit. This specialized service is crucial for navigating the complexities of custom-made devices under Annex XIII of the MDR.
Key Highlights
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Acts as the Legal Manufacturer for MDR-compliant custom-made 3D-printed medical devices.
Source
“BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance.”
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Provides end-to-end solutions from strategy and funding to development, manufacturing, and regulatory compliance.
Source
“From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance.”
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Specializes in Class I-III medical devices, including implants and wearables.
Source
“They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.”
Certifications & Trust Signals
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Headquartered in the Netherlands, serving the EU market.
Source
“F. Hazemeijerstraat 800 – Building A04 7555 RJ Hengelo The Netherlands”
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end support
- Innovators of Class I-III devices, including implants and wearables
- Companies needing regulatory compliance for 3D-printed medical devices
How engagement typically works
- End-to-end partnership
- Acting as Legal Manufacturer for specific device types
Typical deliverables
- Regulatory compliance strategy
- Technical files
- Statement Annex XIII (for MDR-compliant 3D-printed devices)
- Market access support
- Product development plans
Good to know
- Best when requiring specialized regulatory support for 3D-printed custom devices under MDR.
HQ:
Hengelo, Netherlands
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
US, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Device Classes Supported:
Class I, Class IIa
PRRC Qualification Summary:
BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance. Hospitals retain responsibility for clinical use, but BAAT shoulders the accountability as the Legal Manufacturer, ending the back-and-forth confusion. This MDR-approved route designates BAAT as the responsible party, safeguarding patient safety and ensuring regulatory compliance in healthcare. The question of “Who is the Legal Manufacturer?” is now solved with BAAT Medical as the Legal Manufacturer and 3DMM as the production expert, this partnership delivers MDR-compliant custom-made devices with transparency and trust.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Implied process involves evaluating value proposition, performing a Business Scan, and developing strategy, funding, development, manufacturing, and compliance plans.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
No
PRRC Qualification Summary
Acts as Legal Manufacturer for MDR compliance, validating processes and creating technical files.
Regulatory Experience
Experience in regulatory compliance for medical devices, including specific expertise in MDR for 3D-printed devices.
